Carotenoids are a group of pigments that are characterized by the color including and ranging from yellow to red. Carotenoids are commonly produced by a wide variety of plant materials and most commonly associated with plants such as tomatoes, carrots and peppers.
Lycopene and its precursor phytofluene are carotenoids commonly found in tomatoes and are the predominant sources of the bright red color associated with tomatoes. Phytoene is a precursor to phytofluene, lycopene and other carotenoids, and is also found in high concentrations in tomatoes. Lycopene is generally present in the plasma of the human body; the serum concentrations of lycopene are typically about 2.5 times higher than those of .alpha.-carotene and 7.5 times greater than those of .beta.-carotene. Carotenoids are known to have antioxidant properties and consequently, provide numerous beneficial health effects including reducing the potential risks of cardiovascular diseases, cancers, and slowing and/or reversing the degenerative effects of aging on various human physiological activities.
Prostate cancer and benign prostatic hyperplasia (also called BPH) are aging-related conditions that affect prostate gland physiology and impair urinary function in men. As many men age, their prostate glands slowly enlarge causing (a) obstructive symptoms exemplified by weak and/or intermittent urinary streams, a sense of residual urine in the bladder after voiding, and dribbling or leakage at the end of urination, and/or (b) irritative symptoms as exemplified by urgency of micturation, increased frequency of urination, and uracratia. Obstructive and irritative urinary symptoms are commonly referred to as lower urinary tract symptoms (LUTS). The current treatments of prostrate cancer, BPH and LUTS symptoms consist of drug therapies and major surgery. The two primary drug classes used are alpha-blockers and 5-alpha-reductase inhibitors, which should be taken for life in order to get the persistent efficacy. When surgery is considered, the results are usually positive, but there are risks associated with such surgical operations.
US Patent Publication 2005/0031557 describes an oral composition containing lutein, phytoene and phytofluene, but professing no preference for any specific amount of either of phytoene or phytofluene relative to lutein or any one of the list consisting of .alpha.-carotene, astaxanthin, .alpha.-cryptoxanthin, .beta.-cryptoxanthin, zeaxanthin, phytoene, phtyofluene, .gamma.-carotene and neurosporin, nor any especially important reason for including any of the members of that list in the composition. The '557 publication fails to indicate any important benefit may be obtained by inclusion of phytoene or phytofluene in the composition relative to any other component thereof.